20 completed, 7 recruiting, 6 active not recruiting, 2 not yet recruiting. 22 Not applicable, 1 Phase 3, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 22 | Completed 13, Recruiting 5, Not yet recruiting 2, Active not recruiting 1, Terminated 1 |
| Phase 3 | 1 | Completed 1 |
| Phase 4 | 1 | Completed 1 |
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Outcomes of an Optimized Workflow With PulseSelect Pulsed Field Ablation (PFA) System in Paroxysmal and Persistent Atrial Fibrillation PulseSelect Pulse Field Ablation (PFA) System - Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation | Not applicable | Not yet recruiting | Medtronic Cardiac Ablation Solutions | 320 | 2026-10-01 | 2026-10-09 |
| Sphere-9 PAF China Study Catheter ablation using Sphere-9™ Catheter and Affera™ Integrated Mapping and Ablation System - Paroxysmal Atrial Fibrillation (PAF) | Not applicable | Not yet recruiting | Medtronic Cardiac Ablation Solutions | 180 | 2026-09-02 | 2026-08-27 |
| Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT) Sphere-9 Catheter with the Affera Mapping and Ablation System - Ventricular Tachycardia | Not applicable | Recruiting | Medtronic Cardiac Ablation Solutions | 260 | 2026-08-17 | 2026-10-13 |
| Conquer-AF Protocol for Redo Ablation Procedures in Recurrent Paroxysmal and Persistent Atrial Fibrillation Using the Sphere-9 Catheter and Affera Ablation System (Conquer-AF) Sphere-9 Catheter Ablation - Atrial Fibrillation (AF), Persistent Atrial Fibrillation | Not applicable | Recruiting | Medtronic Cardiac Ablation Solutions | 400 | 2026-04-08 | 2026-10-19 |
| Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360) Sphere-360 Pulsed Field Ablation Catheter with the Affera Mapping and Ablation System - Paroxysmal AF | Not applicable | Active not recruiting | Medtronic Cardiac Ablation Solutions | 300 | 2026-01-15 | 2026-09-02 |
| SPHERE Per-AF Post-Approval Study Sphere-9™ Catheter and Affera™ Ablation System - Persistent Atrial Fibrillation | Active not recruiting | Medtronic Cardiac Ablation Solutions | 200 | 2025-09-25 | 2026-06-18 | |
| Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS) Sphere-9 Catheter with the Affera Mapping and Ablation System - Ventricular Tachycardia (VT) | Not applicable | Recruiting | Medtronic Cardiac Ablation Solutions | 60 | 2025-03-18 | 2026-09-03 |
| PULSED AF Post-Approval Study PulseSelect™ PFA system - Atrial Fibrillation | Recruiting | Medtronic Cardiac Ablation Solutions | 580 | 2024-11-04 | 2026-09-22 | |
| PulseSelect™ PFA Global Registry Atrial Fibrillation | Recruiting | Medtronic Cardiac Ablation Solutions | 1950 | 2024-07-23 | 2026-10-16 | |
| Affera Global Registry Affera Platform - Atrial Fibrillation | Active not recruiting | Medtronic Cardiac Ablation Solutions | 540 | 2023-12-22 | 2026-10-09 | |
| STOP AF First Post-Approval Study Arctic Front™ Cardiac Cryoablation Catheter - Paroxysmal Atrial Fibrillation | Active not recruiting | Medtronic Cardiac Ablation Solutions | 200 | 2022-04-28 | 2026-09-23 | |
| DIAMOND AF Post-Approval Study DiamondTemp™ Ablation System - Paroxysmal Atrial Fibrillation | Terminated | Medtronic Cardiac Ablation Solutions | 84 | 2022-02-28 | 2026-07-06 | |
| Treatment of Persistent Atrial Fibrillation With Sphere-9 Catheter and Affera Mapping and Ablation System Mapping and Ablation - Atrial Fibrillation | Not applicable | Completed | Medtronic Cardiac Ablation Solutions | 477 | 2021-12-14 | 2025-04-23 |
| Safety and Performance of the Affera SpherePVI™ Multi-Ablation System to Treat Paroxysmal Atrial Fibrillation SpherePVI™ Catheter - Atrial Fibrillation | Not applicable | Recruiting | Medtronic Cardiac Ablation Solutions | 150 | 2021-10-19 | 2026-09-15 |
| STOP Persistent AF PAS Arctic Front™ Cardiac Cryoablation Catheter System - Persistent Atrial Fibrillation | Active not recruiting | Medtronic Cardiac Ablation Solutions | 400 | 2021-08-19 | 2026-07-22 | |
| Safety and Performance of the SpherePVI™ Catheter to Treat Paroxysmal Atrial Fibrillation SpherePVI™ Catheter - Atrial Fibrillation | Not applicable | Recruiting | Medtronic Cardiac Ablation Solutions | 100 | 2021-07-22 | 2026-09-15 |
| DiamondTemp Global Registry DiamondTemp™ Ablation System - Arrhythmia | Active not recruiting | Medtronic Cardiac Ablation Solutions | 545 | 2021-04-22 | 2026-05-27 | |
| Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF Medtronic PulseSelect Pulsed Field Ablation (PFA) System - Atrial Fibrillation | Not applicable | Completed | Medtronic Cardiac Ablation Solutions | 421 | 2019-12-10 | 2025-02-13 |
| ArcticLine Feasibility Study ArcticLine Cardiac Cryoablation Catheter - Atrial Fibrillation, Atrial Flutter | Not applicable | Completed | Medtronic Cardiac Ablation Solutions | 17 | 2018-10-18 | 2025-02-13 |
| DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation Radiofrequency Ablation - Persistent Atrial Fibrillation, Atrial Fibrillation | Not applicable | Completed | Medtronic Cardiac Ablation Solutions | 376 | 2018-09-19 | 2025-10-23 |
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Atrial Fibrillation (32) · Arrhythmias, Cardiac (4) · Atrial Flutter (3) · Heart Diseases (3) · Tachycardia, Ventricular (3) · Cardiovascular Diseases (2) · Myocardial Ischemia (2) · Pathologic Processes (2) · Bradycardia (1) · Tachycardia (1) · Tachycardia, Atrioventricular Nodal Reentry (1) · Tachycardia, Supraventricular (1)
Anti-Arrhythmia Agents (2) · Drug Delivery Systems (2) · Catheter Ablation (1) · Cryosurgery (1) · Radiofrequency Ablation (1)
United States (21) · France (14) · Czechia (11) · Germany (11) · Italy (11) · Canada (10) · Spain (9) · Netherlands (8) · Belgium (7) · Switzerland (7) · United Kingdom (7) · Australia (5) · Greece (5) · Austria (4) · Hungary (4)
Khaldoun Tarakji, MD (7) · Vivek Reddy, MD (4) · Atul Verma, MD (2) · Andrea Natale, MD (1) · Angel Ferrero, MD (1) · Bradley P. Knight, MD, FACC, FHRS (1) · Frank Pelosi, M.D. (1) · Gerhard Hindricks, Prof. (1) · GianBattista Chierchia, MD (1) · Gopi Dandamudi, MD (1) · Hugh Calkins, MD (1) · Jason Andrade, Prof. (1)
PMID 38007219, PMID 26283655, PMID 27042964, PMID 27381589, PMID 28750697, PMID 28751544, PMID 29044787, PMID 29700058, PMID 30466850, PMID 30898232, PMID 31693319, PMID 32590151, PMID 33197158, PMID 33516712, PMID 34089431, PMID 34446764, PMID 34508694, PMID 34889108, PMID 34964367, PMID 36097833, PMID 36331681, PMID 36877118, PMID 36908163, PMID 37071112, PMID 37211146, PMID 37505337, PMID 38082096, PMID 38760584, PMID 38956935, PMID 39136617, PMID 39243306, PMID 39836630, PMID 39922404, PMID 40529551, PMID 40545038, PMID 40928625, PMID 41655663, PMID 41727702